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December 1995


As defined by the Codex Alimentarius Commission (a joint FAO/WHO organisation

involved in preparing food standards) and the EEC Commission, a 'food additive'
means any substance not normally consumed as a food by itself and not normally
used as a typical ingredient of food, whether or not it has nutritive value, the
intentional addition of which to food for a technological (including organoleptic)
purpose in the manufacture, processing, preparation, treatment, packing, packaging,
transport or holding of such food results, or may reasonably be expected to result,
directly or indirectly, in it or its by-products becoming a component of or otherwise
affecting the characteristics of such foods. The term does not include contaminants or
substances added to food for maintaining or improving nutritional qualities.

Although food additives are in no way uniquely related to allergic or intolerance

reactions, this criticism is often made. This factsheet seeks to address this issue and
put it in context.


Additives may be classified into three groups, according to the function they fulfil.
Some additives fulfil more than one function.

a) Additives affecting physical or physico-chemical characteristics:

thickeners (including starches, gums, pectin)

emulsifiers and stabilisers
acidulants and buffers
clouding/weighting agents (dispersing agents)
raising agents
anti-caking agents
glazing agents

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b) Additives affecting sensory characteristics:

thickeners (including starches, gums, pectin)

emulsifiers and stabilisers
acidulants and buffers
clouding/weighting agents (dispersing agents)
raising agents
anti-browning agents
sequestering agents

curing and pickling agents

flavour enhancers
gelling agents
non-nutritive sweeteners
flour improvers

c) Additives affecting shelf-life:

anti-browning agents
sequestering agents
curing and pickling agents


Additives have been used from earliest times. For example, the ancients preserved
food with vinylguaiacol and chemically related substituted phenols (in the form of
smoke), acetic acid (in the form of vinegar), sulphur dioxide (from burning sulphur),
sodium chloride and other metal halides and sulphates (in the form of sea-salt and
brine). They coloured food with 1-methyl-2-carboxy-3,5,6,7,8,
pentahydroxyanthraquinone-7-glucoside (in the form of cochineal, the crushed insect
Coccus cacti) and crocetin digentiobiose ester (in the form of saffron). They used gum
arabic (and other exudates) as thickeners and emulsifiers.

Some of these additives were multifunctional. Some common ingredients such as

smoke, salt and vinegar have also a preservation function, but also change flavour.
Saffron adds flavour in addition to colour.

Most of the ancient additives are still in use. With time, their number, though not
necessarily the total quantity, has increased, mainly in pursuit of the original aims but
additionally in the interest of safety.

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4.1. Definition of adverse reactions to food (allergy and intolerance)

Adverse reactions from ingestion of food additives could be of two different types: true
allergy or hypersensitivity, which results from an immunological mechanism, and
intolerance or idiosyncrasy, where no immunological basis is apparent. The
mechanisms of these reactions are not totally clear but it seems that virtually all the
adverse reactions to food additives are manifestations of intolerance rather than

4.2. Clinical Symptoms

A food additive ingested by anyone susceptible to it produces symptoms which cause

variable degrees of discomfort.

The most common manifestations of intolerance occur in the respiratory tract

(particularly asthma and rhinitis) and the skin (usually urticaria or angiodema).
Migraine, irritable bowel syndrome, psychological disturbances, urinary incontinence
and arthralgia have been reported, however the association is less clear.

The popular press has given prominence to claims that additives are responsible for
hyperactivity in children. Hyperactivity is mainly characterised by constant
restlessness, disorganization and inattention.

The much-publicised claim by Feingold that additives induce hyperactivity in children

has been refuted by a report of the American Council on Science and Health (ASCH)
in 1982. Recent well-controlled scientific studies support a link between food additives
and hyperactivity in only a small proportion of cases of hyperactivity in small children.

The Joint Report of the Royal College of Physicians and the British Nutrition
Foundation 1984 regarding "Food Intolerance and Food Aversion" states:

"The diversity of clinical manifestations means that there is no particular diagnostic

sign. Elimination diets and "blind" challenges require much time by clinician and
patient, and the interpretation of results may not always be objective. It is a reflection
of the difficulties of accurate diagnosis that estimates of incidence of susceptibility are
variable and tentative."

Furthermore, additives to be used in foodstuffs for infants, and young children are
evaluated in the EEC separately from other additives, by a specific procedure

4.3. Frequency of adverse reactions

Assessing the frequency of allergy or intolerance to food additives, poses a

considerable problem. According to the Working Group Report of the EEC, (Scientific
Committee for Food, Report III/556/81, 1981) there is no doubt about the existence of
such reactions to individual food additives, particularly urticaria and respiratory
reactions which can be provoked by several commonly used food colours,
preservatives and antioxidants. However, for most additives, no history of causing
adverse reactions is known.

Difficulty in obtaining evidence of susceptibility is that data are mainly obtained from
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highly selected groups of patients with skin or respiratory disorders. Food additives, if
they have any influence on the condition, may exacerbate a pre-existing intolerance
caused by an entirely different agent.

The Working Group Report of the EEC, 1981, reports some estimates of intolerance
incidence and from a variety of studies in several countries it draws the following

"Therefore when attempting to quantify the problem of adverse reactions to food

additives, it is only possible, on the basis of present information, to suggest a wide
range of possible frequencies, and only for the most common manifestations, of
0.03% to 0.15%".

A more recent study carried out on behalf of the British Government confirms that the
occurrences of intolerance reactions to additives is low and in the general population
is in the range of 0.01-0.26%.

4.4. Adverse Reactions in Context

The estimate of 0.03 - 0.15% intolerance to additives should be viewed in the context
of intolerance to other food and food ingredients. To estimate the incidence of such
intolerance is as difficult as it is for additives, and for the same reasons. Estimates
therefore vary widely: between 0.3 and 20%.

The most common allergy among young children, estimated at between 0.2 and
7.5%, is to cow's milk protein. Among adults the commonest allergies are to cow's
milk, eggs, fish and shellfish, wheat and wheat products and soya.

A significant proportion of the world's population can only tolerate small amounts of
milk. This is because they lack the enzyme, lactase, necessary to digest lactose.
This lactase-deficiency reaches 90% of some ethnic groups but is less than 10%
among European Caucasians.

There is no food or ingredient which does not have an adverse effect on somebody
and additives are a diverse group of substances with no form or function common to
all. The assertion that some people are intolerant to all additives but to nothing else is
both contrary to reason and without evidence.


The use of additives is strictly regulated in all developed countries. The regulatory
mechanisms differ in detail from one area to another but all aim to ensure safety by
defining what additives may be used, in what amount, in what type of food and based
on technological need. Examples are:

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5.1. Regulation in the EEC

Regulations are based on the toxicological evaluations of the Scientific Committee for
Food of the European Union. This committee is composed of acknowledged experts
from all the member countries. They rely on their own work, and on guidance from
the Joint FAO/WHO Expert Committee on Food Additives and the World Health

Once permitted, an additive goes on the list of permitted additives and is given a
number prefixed by the letter "E". The presence of an additive in food must be stated
on packaging after its category name, either by its "E" number or its scientific name,
e.g. "E330" or "citric acid". An E number indicates that the additive is approved for
use throughout the EEC. It also enables consumers, by use of a key, to identify an
additive whatever their language.

Recently, the E.U. adopted three specific directives regulating the use of all additives
in foodstuffs.

5.2. Regulation in the US

Additives are regulated by the Food and Drug Administration. Those in common use
before 1958 are classified as "GRAS" (General Regarded as Safe) and are excluded
from the legal definition of additives.

Additives which are not classified as GRAS under the old 1958 rules are controlled by
regulations made under a 1958 Food Additive Amendment to the Food, Drug and
Cosmetic Act. These regulations specify what toxicological criteria are necessary for
additive clearance and include special requirements (the "Delaney Clause") for
additives suspected of causing cancer. If there are sound grounds for concern, an
additive can be delisted under either the old or new systems of clearance.

5.3. Regulation in Australia

In Australia, the system of approval is slightly different but it embodies the same
principles of control. No new additive is approved for use in food before its safety has
been established by the National Health and Medical Research Council (NH & MRC),
and it is then adopted into the Australian Food Standards Code for national use. All
ingredients and additives in food are controlled by the Food Standards Code and the
State Health Departments and are permitted only in foods where stated so in the

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Additives are used primarily to make food products safe, convenient and attractive.

They may only be used when the regulatory authorities are satisfied that they are both
safe and necessary for their purpose.

A very small minority of people are intolerant to individual additives. Intolerance to

food additives is less frequent than allergic reactions to certain foods or components
of food (e.g. milk protein).

A listing of ingredients allows those who are intolerant to certain ingredients to avoid
food which contains them.


1. CARTER, C.M. URBANOWITZ, M. HEMSLEY, R. 1993. Effects of a few food diet in

attention disorders. Arch. Dis. Child. 69 564-568.

2. CODEX ALIMENTARIUS COMMISSION (1979) "Guide to the safe use of food


3. COMMISSION OF THE EUROPEAN COMMUNITIES (1980) "Food additives and the


4. Commission of the European Communities Reports of the Scientific Committee for

Food (Twelfth Series). Report of the Scientific Committee for food on the sensitivity
of individuals to food components and food additives. Brussels, Commission of the
European Communities, 1981. (EUR 7823).

5. DAVID, T.J. (1993) Food and Food Additive Intolerance in Childhood. Blackwell
Scientific Publications.

6. FOLKENBERG, J. (1988) Reporting reactions to additives. In: An FDA Consumer

Special Report-Safety First: Protecting America's Food Supply. Rockville, MD: Dept
of Health and Human Services, HHS Publication No (FDA) 88-2224.

7. GROUP OF EUROPEAN NUTRITIONISTS, 28th Symposium ('1991) Food Allergy

and Food Intolerance: Nutritional Aspects and Developments ! KARGER

8. INSTITUTE OF FOOD SCIENCE AND TECHNOLOGY (1986), "Food additives - the

professional and scientific approach", London, IFST, 20pp.

9. LESSOF, M.H. (1994). Food Allergy and other Adverse Reactions to Food ILSI
Europe Concise Monograph Series.

10. Medical Aspects of food intolerance: a group of research papers sponsored by the
Ministry of Agriculture, Fisheries and Food. Journal of the Royal College of
Physicians, 1987, 21, N°4.

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Physicians report.

12. PERKIN, J.E. (1990) Food Allergies and Adverse Reactions. Aspen Publications.

13. POLLOCK, I. & WARNER, J.O. (1990) Effect of food colour on childhood behaviour.
Arch. Dis. Child 65 74-77.

14. ROYAL COLLEGE OF PHYSICIANS OF LONDON (1984) "Food intolerance and

food aversion - a joint report of the Royal College of Physicians and the British
Nutrition foundation". Journal of the Royal College of Physicians of London, 18 N° 2.

15. YOUNG, E. et al. (1987) The prevalence of reaction to food additives in a population
survey. Journal of the Royal College of Physicians, 21, 241-247.


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